A Study Comparing Single-Port and Multi-Port Robot-Assisted Surgery in Patients With Prostate or Kidney (Renal) Cancer

May 20, 2026 updated by: Francesco Montorsi, IRCCS San Raffaele

Single-port vs. Multi-port Robot-assisted Surgery for Prostate or Renal Cancer

This is a prospective single-center observational study comparing single-port (SP) and multi-port (MP) robot-assisted surgery in adult patients undergoing robot-assisted radical prostatectomy (RARP) or robot-assisted partial nephrectomy (RAPN) for prostate or kidney cancer.

Consecutive eligible patients will be managed according to routine clinical practice and assigned to SP or MP surgery based on predefined clinical and anatomical criteria, surgeon assessment, patient and tumor characteristics, platform availability, and surgical expertise. No randomization will be performed.

The study aims to compare perioperative outcomes between the two surgical approaches, with length of hospital stay (LOS) as the primary endpoint. Secondary endpoints include intraoperative outcomes (operative time, estimated blood loss, and intraoperative complications), postoperative recovery, pain, postoperative complications, readmission rates, positive surgical margins, and hospital costs.

Functional and patient-reported outcomes will also be evaluated, including urinary continence, sexual function, health-related quality of life, renal function after partial nephrectomy, decision regret, and cosmetic satisfaction.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This prospective observational cohort study is conducted at a single high-volume tertiary referral center performing robot-assisted urologic surgery using both single-port (SP) and multi-port (MP) robotic platforms.

The study includes consecutive adult patients (≥18 years) undergoing robot-assisted radical prostatectomy (RARP) or robot-assisted partial nephrectomy (RAPN) for prostate or kidney cancer during the study period.

Treatment allocation is not randomized. The choice between SP and MP surgery is made in routine clinical practice by the treating surgeon based on predefined clinical and anatomical criteria, including patient characteristics, tumor features, surgical indication, platform availability, and surgeon experience.

The primary objective is to compare perioperative outcomes between SP and MP robotic-assisted surgery, with length of hospital stay (LOS) defined as the primary endpoint. LOS is measured from the end of surgery (skin closure) to hospital discharge according to standardized discharge criteria.

Secondary outcomes include intraoperative parameters (operative time, estimated blood loss, intraoperative complications), postoperative recovery assessed by validated measures, pain scores, postoperative complications graded by Clavien-Dindo classification, readmission rates, positive surgical margins, and total hospital-related costs.

Additional secondary outcomes include functional outcomes after RARP (urinary continence, sexual function, and health-related quality of life), renal function after RAPN (estimated glomerular filtration rate), decision regret, and cosmetic satisfaction and body image perception.

All outcomes are collected prospectively according to predefined time points within routine follow-up schedules.

Study Type

Observational

Enrollment (Estimated)

376

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male or female participants (≥18 years old) with a diagnosis of prostate or renal cancer candidates for RARP or RAPN.

Description

Inclusion Criteria:

  • The participant provides written informed consent
  • Male or female participants who are at least 18 years of age on the day of signing informed consent
  • Men with a diagnosis of prostate or renal cancer and women with a diagnosis of renal cancer
  • Pre-operative imaging performed for staging purposes (i.e. CT scan, PSMA PET) showing no suspicious evidence of distant metastases in prostate or renal cancer patients
  • Suitable for RARP or RAPN.

Exclusion Criteria:

  • Patients < 18 years
  • Mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
  • Inability to read and sign the informed consent
  • No available pre-operative staging
  • Contraindication to surgery
  • Presence of distant metastases (M1)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Single-Port Robot-Assisted Surgery
Multi-Port Robot-Assisted Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay (LOS)
Time Frame: Day 30
Length of hospital stay (LOS), defined as the time from the end of surgery (skin closure) to hospital discharge, expressed in days or hours. Discharge will be based on predefined and standardized discharge criteria.
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PORTAL Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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